Job Description
OBJECTIVES/PURPOSE:
- Provides support to senior team members to define, develop and lead the Regional (Europe & Canada [EUCAN] GI&I strategies to maximize regulatory success and strengthen the product development plan in support of enabling patient access, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management
- May collaborate with the global, regional, and local team to enable patient access in alignment with program objectives and timely approval of investigational applications and life-cycle management applications, while maintaining full compliance with applicable regulatory requirements.
- Contributes to the Submission Working Group and represents the region as needed on global and project teams.
- Under the supervision of a senior team member and/or Line Manager, supports interactions with health authorities in the region for products within their responsibility.
ACCOUNTABILITIES:
- Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors
- Supports collaboration with Takeda Global, Regional counterparts, Local Regulatory Affairs, and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed in line with product team objectives.
- Supports a more senior regulatory lead for assigned assets and/or projects
- Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments to assigned programs and presents regional regulatory strategies to leadership/senior management
- Stays current with regulations / guidance in the region and in coordination with local regulatory leads and Global Regulatory Policy & Innovation, provides strategic advice on emerging trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
- In alignment with line manager, may provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Prepares and maintains regulatory planning/filing documents for assigned products in the region.
- Participates, as appropriate, and authors/reviews internal procedures and processes.
- Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
- Supports Access to Medicines initiatives to develop and implement innovative patient access strategies. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
- Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross- functional Teams; company's consultants and Business Partners as required.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc. Advanced scientific related degree preferred; BA accepted based on experience.
- Experience in drug regulatory affairs / within the pharmaceutical industry in the EU/GEM region is preferable.
- Some experience in managing filings
- Knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU/GEM region
- Analyzes issues with attention to detail and makes reasoned recommendations
- Can speak up and influence in cross-functional / global teams
- Expresses empathy for others
- Practices active listening, encourages open dialogue, feedback, and diverse opinions
- Is able to carry out assigned activities within reasonable time. Applies the given prioritization framework with limited support
- Fluency in English
- TRAVEL REQUIREMENTS:
- Requires Willingness to travel to various meetings, including overnight trips. approximately up to 10% travel.
Locations
Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
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What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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